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Идёт набор NCT07109349

tAN for First Responders

Без фазы С лечением Mental Fatigue Mental Stress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sparrow Link.
Кому может быть актуально
Состояния в реестре: Mental Fatigue, Mental Stress. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Effect of Transcutaneous Auricular Neurostimulation on Mental Wellness and Resiliency for First Responders: A Pilot Trial

Обзор

This study is designed as an open label, single arm, decentralized clinical study in which first responders will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled in the study over the course of eight weeks (56 days). Participants will respond to daily and weekly questionnaires regarding mood, stress, sleep, energy/fatigue, and burnout. Each week, participants will complete consolidated online questionnaires (intended to last no longer than 15 minutes) comprised of the Perceived Stress Short-Form (PSS-4), Well-Being Index (WHO-5), Mini-Z Burnout (5-item), PROMS Sleep Disturbance (PROMIS-SD), GAD-7 (every 2 weeks), and Perceived Stress (PSS-10; monthly). The PSS-10 will replace the PSS-4 on Days 0, 28, and 56. No tAN treatment will be delivered during the Baseline Period (days between Study Introduction and Day 0). Participants will complete the weekly set of questionnaires ("Weekly Questionnaires") on Day 0. Participants will be recommended to complete the daily set of questionnaires ("Daily Questionnaires ") on the other days of the Baseline Period. On Days 1 - 28, participants will self-administer one session of one to two hours of tAN therapy each day. Participants will be recommended to complete the daily tAN session post-shift prior to sleep. Weekly Questionnaires will be completed by participants on Study Days 0, 7, 14, 21, 28, 35, 42, 49, and 56. Participants will be recommended to complete Daily Questionnaires on all other study days, up to Day 28. Daily Questionnaires will not be required to be completed by participants. Daily tAN sessions and Daily Questionnaires will cease after Day 28. Participants will complete a Study Satisfaction Questionnaire with the Weekly Questionnaires on Day 56. Following Day 56, participants will schedule a Study Exit Interview with the Research Coordinator.

Вмешательства

  • Устройство Sparrow Link
    Sparrow Link will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. Participants will self-administer daily active tAN sessions on Days 1 - 28.

Первичные конечные точки

  • GAD-7 [Срок оценки: Screening, Day 0, Day 14, Day 28, Day 42, Day 56]
Вторичные конечные точки (4)
  • Perceived Stress Scale (PSS-4, PSS-10) [Срок оценки: Weekly throughout enrollment beginning Day 0 through Day 56)]
  • PROMIS Sleep Disturbance [Срок оценки: Weekly throughout enrollment beginning Day 0 through Day 56)]
  • WHO-5 Well-Being Index [Срок оценки: Weekly throughout enrollment beginning Day 0 through Day 56)]
  • Mini-Z Burnout Survey [Срок оценки: Weekly throughout enrollment beginning Day 0 through Day 56)]

Критерии участия

Критерии включения

  • Participant is currently employed in a first responder position
  • Age ≥ 18 years
  • Reliable access to an internet-enabled device to complete required questionnaires
  • GAD-7 score ≥ 5

Критерии исключения

  • Participant has a history of epileptic seizures
  • Participant has a history of neurologic diseases or traumatic brain injury
  • Participant has presence of devices (e.g., pacemakers, cochlear prostheses or implants, neurostimulators)
  • Participant has abnormal left ear anatomy or ear infection present
  • Participant has auditory impairment of the left ear (ruptured eardrum, deafness, tinnitus, etc.)
  • Participant is currently enrolled in another interventional trial
  • Women of childbearing potential, not using adequate contraception as per the investigator's judgement
  • Females who are pregnant or lactating
  • Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Spark Biomedical - DECENTRALIZED STUDY — Dallas

Идентификаторы

NCT: NCT07109349 · SBM-MRES-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗